TB Type and Spirometry Result vs. Functional Capacity Based on 6MWT in People With Post-TB Lung Disease

NCT07451899 | Not Yet Recruiting

• 1 other identifier: IKFR-202602.01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Post-Tuberculosis Lung Disease (PTLD) is defined as chronic respiratory impairment due to previous pulmonary TB. Children recovering from pulmonary TB undergo ongoing respiratory health challenges, including more frequent respiratory symptoms, reduced lung volumes, and a threefold higher rate of pulmonary dysfunction compared to healthy children. These conditions could lead to long-term health consequences such as difficulties in performing daily activities. Pulmonary function impairment in PTLD includes approximately 10% of patients losing more than 50% of lung function. Adolescents who have undergone TB treatment often experience pulmonary function impairment and reduced physical capacity. This aims of this study is to analyze the correlation between type of tuberculosis, spirometry result, and functional capacity in adolescents with post-tuberculosis lung disease. This study is an analytical observational study with a cross-sectional approach. This study is conducted at Department of Physical Medicine and Rehabilitation, Hasan Sadikin Hospital, Bandung, starting in March until May 2026. Inclusion criteria including: adolescents (10-18 year old), and diagnosed with post tuberculosis lung disease by pediatrician, and capable of performing the 6MWT. The participants with post TB lung disease will undergo spirometry and functional capacity assessment using the 6-minute walk test (6MWT). Outcomes include spirometry result and functional capacity using 6MWT.

Conditions

Post Tuberculosis; Lung Disease; Functional Capacity; Spirometry

Outcome Measures

Primary Outcomes (3)

• Change in 6-Minute Walk Distance (6MWD) measured in METs

  Functional capacity will be assessed using the standardized 6-Minute Walk Test (6MWT), conducted according to American Thoracic Society guidelines. Participants will be instructed to walk back and forth along a marked corridor for six minutes, and the total distance covered will be recorded in meters. In addition, metabolic equivalents (METs) will be estimated from walking speed using the ACSM walking equation: VO₂ (ml/kg/min) = 3.5 + 0.1 × speed (m/min), with METs calculated as VO₂/3.5. Both outcomes-distance in meters and estimated METs-will be reported as mean change from baseline at the specified time points.

  12 weeks

• Forced Expiratory Volume in 1 second (FEV1) in liter

  Spirometry will be performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform a forced vital capacity (FVC) maneuver consisting of full inspiration to total lung capacity, followed by a rapid, forceful, and sustained expiration into the mouthpiece for at least 6 seconds (or until a volume plateau is achieved). A subsequent rapid inspiration will be performed to complete the flow-volume loop when required. A minimum of three acceptable maneuvers will be obtained for each participant to ensure reproducibility. From these maneuvers, Forced Expiratory Volume in 1 second (FEV1) will be recorded in liters at each assessment time point and summarized as mean and standard deviation across participants.

  12 weeks

• Forced Vital Capacity (FVC) in liters

  Spirometry will be performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform a forced vital capacity (FVC) maneuver consisting of full inspiration to total lung capacity, followed by a rapid, forceful, and sustained expiration into the mouthpiece for at least 6 seconds (or until a volume plateau is achieved). A subsequent rapid inspiration will be performed to complete the flow-volume loop when required. A minimum of three acceptable maneuvers will be obtained for each participant to ensure reproducibility. From these maneuvers, Forced Vital Capacity (FVC) will be recorded in liters at each assessment time point and summarized as mean and standard deviation across participants.

  12 weeks

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Post tuberculosis patient who come to Department of Physical Medicine and Rehabilitation, Hasan Sadikin Hospital, Bandung

You may qualify if:

• Adolescents (10-18 year old)
• Diagnosed with post tuberculosis lung disease by pediatrician
• Capable of performing the 6MWT

You may not qualify if:

• Diagnosed with another lung disease
• Having physical limitations that hinder the 6MWT

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Irma R Defi, MD, PhD

  Hasan Sadikin General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma R Defi, MD, PhD

CONTACT

+6216908139; irmaruslina@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

ID (1)